BEUDAMED
    FDA Adverse Event Other Summary report: N

    MERON (APPLICATION CAPSULE)

    MDR report key: 4454495 · Received January 14, 2015

    Report

    Report Number
    8010908-2015-00001
    Event Type
    Other
    Date Received
    January 14, 2015
    Report Date
    January 13, 2015
    Manufacturer
    VOCO GMBH
    Product Code
    EMA
    PMA / PMN Number
    K130421
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT DEFECT WAS FOUND AS A RESULT OF TESTING CARRIED OUT ON THE MATERIAL RETURNED TO US. THE USER'S REPORT DOES NOT CONTAIN ANY INDICATION OF PRODUCT FAILURE EITHER. WE HAVE CONTACTED THE DENTIST TO CLARIFY THE LIKELY CAUSES BY A MALFUNCTION, FAILURE OR DETERIORATION IN THE CHARACTERISTICS OR THE PERFORMANCE OR AN INADEQUACY IN THE LABELING OR THE INSTRUCTIONS FOR USE OF THE PRODUCT. A VARIETY OF TREATMENTS WITH THE SAME BATCH WERE CONDUCTED WITHOUT ANY PROBLEMS. A PULP PROTECTION WAS NOT APPLIED. WE CONSIDER IT UNLIKELY THAT MERON, CAUSES THE ABOVE MENTIONED SYMPTOMS WHEN USED PROPERLY. THE CASE WAS ASSIGNED TO THE DÉPARTEMENT OF RECLAMATIONS AND DOCUMENTED. NO REPORTS HAVE BEEN RECEIVED REGARDING OTHER CASES OF THIS TYPE IN RELATION WITH MERON. IN SUMMARY OF THE EVALUATION OF INFORMATION RECEIVED ON THIS INCIDENT, THE TESTING RESULTS AND THE ASSESSMENT OF THE HISTORY OF COMPLAINTS WERE PROBABLY IATROGENICALLY INDUCED. NO CORRECTIVE MEASURES HAVE BEEN SCHEDULED IN CONSEQUENCES OF THIS INCIDENT. NONE PRODUCTS WITH THIS LOT # WAS SUPPLIED TO THE UNITED STATES.

    Description of Event or Problem · 1

    A DENTIST ALLEGED, BETWEEN 6-8 WEEKS AND 3-4 MONTHS AFTER PLACEMENT OF RESTORATIONS WITH MERON, THE PATIENTS EXPERIENCED OCCLUSAL SENSITIVITIES WITH SUBSEQUENT PULPITIS. HE SAID, THAT 7-8, BUT NOT MORE THAN 10 TEETH FROM DIFFERENT PATIENTS WERE AFFECTED. THE TEETH WERE TREPANNED AND ROOT CANAL TREATMENTS WERE CONDUCTED. TO OUR KNOWLEDGE, THE RESTAURATIONS WERE NOT REMOVED. THE INCIDENTS OCCURRED BETWEEN AUTUMN 2013 AND SUMMER 2014. DETAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34795 MERON (APPLICATION CAPSULE) NA EMA VOCO GMBH 1410403

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention